Comparison of Motor and Sensory Response With Interstim Stimulation

NCT00943904 | Completed Results DMC

• 1 other identifier: 2009-6799
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

Sacral nerve stimulation (SNS) implantation is a minimally invasive procedure which has current FDA approval for urinary urge incontinence, urgency-frequency syndrome and non-obstructive urinary retention, and has been available in the United States since 1997. The SNS delivers non-painful, mild electrical pulses to the sacral nerves to modulate the reflexes that influence the bladder, sphincter, and pelvic floor to improve or restore normal voiding function. While SNS has been shown to have efficacy for the aforementioned conditions, the exact mechanism of action is unknown, but it is believed to work primarily through the somatic afferent system in promoting inhibitory reflex pathways to facilitate urine storage. The degree of stimulation is thought to be at a level that only evokes a sensory and not a motor response; however this has not been tested.

Conditions

Overactive Bladder; Urgency-Frequency

Keywords

urinary leakage associated with urinary urgency; unable to fully empty bladder; Comparison: Motor&Sensory Response to Interstim Stimulation

Outcome Measures

Primary Outcomes (1)

• Percent of Symptoms With Improvement of Leaks Reported

  Percent change in improvement of symptoms after reprogramming in terms of number of leaks reported. Nocturia refers to leaks that happened while asleep. Incontinence refers to both stress and urge leaks. Urgency refers to only urge leaks. Positive values represent more improvement of symptoms and therefore less leaks. Negative values represent less improvement and therefore more leaks.

  6 months following enrollment

Study Arms (1)

Interstim stimulation

EXPERIMENTAL

Patients who receive the interstim implant in order to evaluate effectiveness of treatment

Device: Interstim implant for SNS

Interventions

Interstim implant for SNS DEVICE

stimulates third sacral nerve root

Also known as: Sacral nerve Stimulation

Interstim stimulation

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• You are eligible to participate in this study if:
• you are at least 18 years of age or older
• you have the capacity to give informed consent
• you are currently implanted with a functioning Interstim device for the treatment of urge urinary leakage or overactive bladder

You may not qualify if:

• You are not eligible to participate in this study if:
• you have a history of an underlying neurologic disorder
• you are currently pregnant, or have an active urinary tract or vaginal infection

Sponsors & Collaborators

• University of California, Irvine: lead

Study Sites (1)

UCI Women's Healthcare

Orange, California, 92868, United States

Location

MeSH Terms

Conditions

Urinary Bladder, Overactive

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Karen Noblett
• Organization: University of California, Riverside

karen.noblett@ucr.edu

(951) 827-7581

Study Officials

• Karen Noblett, MD

  University of California, Irvine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Division Director

Study Record Dates

• First Submitted: July 20, 2009
• First Posted: July 22, 2009
• Study Start: July 1, 2009
• Primary Completion: February 1, 2012
• Study Completion: February 1, 2012
• Last Updated: October 6, 2021
• Results First Posted: October 6, 2021

Record last verified: 2021-08

Locations

US (1)